chapter1.3

For the use only of a registered medical practitioner or a hospital or a laboratory.

A CONTROLLED TRIAL OF ALOES COMPOUND* IN CASES OF STERILITY AND MENSTRUAL IRREGULARITY

BY
Dr. (Mrs.) S. Agrawal
M.O., D.G.O.
Associate Professor in Obstetrics & Gynaecology,
Govt. Medical College, Nagpur 440 009, Maharashtra.

Paper Presented at First Asian Congress of Induced Abortion and Voluntary Sterilisation, 4–9 March 1979 – Bombay.

The Medicine & Surgery, Vol. No. XXV, No. 4, PP i–4, April 1985.

INTRODUCTION

When we are faced with the problem of menacing population growth, it is strange to see that the problem of infertile couples is confronting us more and more.

One of the most vexing problems of gynaecology is the management of a sterile couple, and in particular, where no definite cause is found.

About 10–15% of couples fail to conceive even though both the partners are normal and where all organic causes are excluded. These couples are termed as having "Low Fertility Index".

ALOES COMPOUND

Aloes Compound was selected for this study. Since the dawn of history a number of species of Aloes are put to various uses.

Gjersted and Riner (1968) have described the use of Aloes as curative, cosmetic and a bitter appetizer.

Aloes Compound contains Aloes (Aloes Indica), Hira Bol (Balsamodendron Myrrh), Kasis Bhasma (Iron Bhasma), Manjishta (Rubia cordifolia), Hurmal (Pegunum harmala), Kamboji (Breynia patens), and Jeevanti (Leptadenia reticulata).

These ingredients act synergistically as an emmenagogue, haematinic, sedative, antispasmodic and appetizer.

MATERIALS & METHODS

For this study cases of Primary & Secondary Sterility that attended the Govt. Medical College Hospital, Nagpur during the period February 1974 to December 1975, were taken at random.

Only those cases that could be followed-up regularly for two years were included in the study.

Study Groups

The trial (Aloes Compound) Group consisted of 120 cases comprising 60 cases of Primary Sterility and 60 cases of Secondary Sterility.

50 cases formed the Control Group, out of which 25 cases were of Primary Sterility and 25 cases were of Secondary Sterility.

MENSTRUAL PATTERNS: TRIAL GROUP

Among the 120 cases of the Trial (Aloes Compound) Group, 25 cases (20.8%) had oligomenorrhoea, 38 cases (31.7%) had irregular periods, and 57 cases (47.5%) had normal periods.

TABLE I — MENSTRUAL PATTERN: TRIAL (ALOES COMPOUND) GROUP

Pattern Primary Sterility % Secondary Sterility % Total %
Oligomenorrhoea 10 16.7% 15 25.0% 25 20.8%
Irregular Periods 20 33.3% 18 30.0% 38 31.7%
Normal Periods 30 50.0% 27 45.0% 57 47.5%
Total 60 100.0% 60 100.0% 120 100.0%

MENSTRUAL PATTERNS: CONTROL GROUP

Among the 50 cases of the Control Group, 8 cases (16%) had oligomenorrhoea, 16 cases (32%) had irregular periods and 26 cases (52%) had normal periods.

TABLE II — MENSTRUAL PATTERN: CONTROL GROUP

Pattern Primary Sterility % Secondary Sterility % Total %
Oligomenorrhoea 3 12.0% 5 20.0% 8 16.0%
Irregular Periods 10 40.0% 6 24.0% 16 32.0%
Normal Periods 12 48.0% 14 56.0% 26 52.0%
Total 25 100.0% 25 100.0% 50 100.0%

DOSAGE OF ALOES COMPOUND

Aloes Compound was given to the Trial Group, 2 tabs. three times a day, continuously for a period of two years or till conception was suspected, if earlier.

All the cases of the Trial and Control Groups received thyroid 1/2 a grain, twice a day and Vitamin B Complex.

RESULTS: MENSTRUAL IMPROVEMENT IN THE TRIAL GROUP

Out of 63 cases of menstrual irregularity of the Trial Group, 60 cases (95.2%) improved their menstrual pattern with Aloes Compound.

TABLE III — RESULTS: ALOES COMPOUND GROUP — MENSTRUAL IMPROVEMENT

1. OLIGOMENORRHOEA

Condition No. of Cases 6M % 12M % 18M % 24M % Total Improved % Not Improved %
Primary Sterility 10 8 80% 1 10% 1 10% - - 10 100% - -
Secondary Sterility 15 9 90% 2 13.3% 1 6.7% 1 6.7% 13 86.7% 2 13.3%
Total 25 17 68% 3 12% 2 8% 1 4% 23 92% 2 8%

2. IRREGULAR PERIODS

Condition No. of Cases 6M % 12M % 18M % 24M % Total Improved % Not Improved %
Primary Sterility 20 8 40% 4 20% 6 30% 1 5% 19 95% 1 5%
Secondary Sterility 18 10 55.5% 6 33.3% 1 5.6% 1 5.6% 18 100% - -
Total 38 18 47.4% 10 26.3% 7 18.4% 2 5.3% 37 97.4% 1 2.6%

RESULTS: MENSTRUAL IMPROVEMENT IN THE CONTROL GROUP

Out of 24 cases of menstrual irregularity of the Control Group, only 2 cases (8.3%) improved in the menstrual pattern.

TABLE IV — RESULTS: CONTROL GROUP — MENSTRUAL IMPROVEMENT

1. OLIGOMENORRHOEA

Condition No. of Cases 6M % 12M % 18M % 24M % Total Improved % Not Improved %
Primary Sterility 3 - - - - 1 - - - 1 33.3% 2 66.7%
Secondary Sterility 5 - - - - - - - - - - 5 100.0%
Total 8 - - - - 1 12.5% - - 1 12.5% 7 87.5%

2. IRREGULAR PERIODS

Condition No. of Cases 6M % 12M % 18M % 24M % Total Improved % Not Improved %
Primary Sterility 10 - - - - 1 - - - 1 10% 9 90.0%
Secondary Sterility 6 - - - - - - - - - - 6 100.0%
Total 16 - - - - 1 6.3% - - 1 6.3% 15 93.7%

RESULTS: CONCEPTION RATE — TRIAL GROUP

Among 120 cases of the Trial (Aloes Compound) Group, 75 cases (62.5%) conceived and 45 cases (37.5%) did not conceive within the trial period of two years.

38.4% of the conception cases conceived within 6–12 months, 14.1% in 18 months and 10% in 24 months.

Conception rate was reported as 65% in cases of Primary Sterility and 60.0% in cases of Secondary Sterility.

TABLE V — CONCEPTION RATE: TRIAL (ALOES COMPOUND) GROUP

Type of Cases No. of Cases 6M % 12M % 18M % 24M % Total Conceived % Not Conceived %
Primary Sterility 60 12 20% 11 18.3% 9 15% 7 11.7% 39 65% 21 35%
Secondary Sterility 60 11 18.3% 12 20% 8 13% 5 8.3% 36 60% 24 40%
Total 120 23 19.2% 23 19.2% 17 14.1% 12 10% 75 62.5% 45 37.5%

RESULTS: CONCEPTION RATE — CONTROL GROUP

Among 50 cases of the Control Group, 10 cases (20%) conceived and 40 cases (80%) did not conceive.

Conception rate was reported as 24% in cases of Secondary Sterility and 16% in cases of Primary Sterility.

TABLE VI — CONCEPTION RATE: CONTROL GROUP

Type of Cases No. of Cases 6M % 12M % 18M % 24M % Total Conceived % Not Conceived %
Primary Sterility 25 2 8% - - 1 4% 1 4% 4 16% 21 84%
Secondary Sterility 25 1 4% 2 8% 1 4% 2 8% 6 24% 19 76%
Total 50 3 6% 2 4% 2 4% 3 6% 10 20% 40 80%

STATISTICAL STUDY: CONCEPTION

Conception took place in 75 cases of the Aloes Compound Group and 10 cases of the Control Group, a total of 85 cases.

45 cases of the Aloes Compound Group and 40 cases of the Control Group, a total of 85 cases did not conceive.

It is hypothetically assumed that the response to Aloes Compound is no better than in Control cases. This is put to statistical test.

Using Chi square test for 2 × 2 contingency tables, the study reports a value corresponding to P < 0.001.

TABLE VII — CONCEPTION: STATISTICAL STUDY

Group Conceived Not Conceived Total
Aloes Compound 75 45 120
Control 10 40 50
Total 85 85 170
Chi Square test for 2 × 2 contingency table: P < 0.001.

The original study states that the assumption was rejected and concludes that statistically Aloes Compound had beneficial action in promoting conception in cases of Primary and Secondary Sterility.

SIDE EFFECTS AND TOXICITY

No side effects or toxicity were observed in the use of Aloes Compound.

CONCLUSION

With the use of Aloes Compound improvement in menstrual pattern was appreciable (95.2%).

Conception rate was high (62.5%).

Statistically, it is proved that Aloes Compound has beneficial action in promoting conception (P < 0.001).

It is concluded that Aloes Compound, which is a nonhormonal drug, can be beneficially used to promote conception in cases of Primary and Secondary Sterility.

ACKNOWLEDGMENT

I am thankful to Dr. P.C. Bansal, Dean, Medical College, Nagpur, for permission to conduct this study and Dr. P. Bhattacharya, Associate Professor of Obst. & Gynec., for her kind support.

I also thank Alarsin Pharmaceuticals, Bombay, for their cooperation.

REFERENCES

1. Balsara, Roshan R (1966): Sterility associated with Irregular and Scanty Menstruation (Use of Aloes Compound as an adjuvant): Indian Pract 1:1, pp. 123-125, Jan. 1966.
2. Gupta, Kusum (1972): “Aloes Compound (A herbal drug in Functional Sterility): XVI All India Obst. & Gynec. Cong. New Delhi, 10-12 March 1972.
3. Jhaveri, C.L.; Munim J.K.; Dass, P.G. (1972): “Clinical Evaluation of Infertility associated with irregular Menstrual Cycles treated with an Indigenous preparation”: XVI All India Obst. & Gynec. Cong., New Delhi, 10-12 March 1972.
4. Khosla, Usha & Khosla, K.C. (1981): “Management of Primary & Secondary Sterility with (1) Aloes Compound (2) D&C/Aloes Compound with Inj. Placentrex”, Medicine & Surgery, Vol. XXI:7, pp. 22-26, July 1981.
5. Mukherjee, Krishna; Pande, M.; Mukherjee, Meena (1972): “A trial of Aloes Compound (an indigenous drug) in cases of Sterility associated with Menstrual Irregularity”, XVI All India Obst. & Gynec. Congress, New Delhi, 10-12 March 1972.
6. Panda, B.C.; Pradhan, S.N.; Parida, H.K. (1980): “Aloes Compound an Ayurvedic Drug in the management of Female Infertility – A Controlled Study”: 56th All India Med. Conf., Cuttack, Orissa, 28-31 Dec. 1980.
7. Panda, Bishnu Charan; Pradhan, S.N.; Parida, H.K. (1981, 1982): “Aloes Compound in the Management of Female Infertility (A Comparative Study with Hormones)”: XXV All India Obst. & Gynec. Congress, Calcutta, 29-31 Dec. 1981; Medicine & Surgery, XXII:5, pp. 41-43, May 1982.
8. Rajasekharan, N.; Vijaya, R.; Rani Uma (1975): “Trial with the Indigenous Drug Aloes Compound in Infertility”: Antiseptic, Vol. 72:2, pp. 451-457, Sept. 1975.
9. Sangamnerkar, A.V. (1979): “Aloes Compound in Sterility”: 21st All India Obst. & Gynec. Congress, Cuttack, Orissa, 27-29 Dec. 1977; Antiseptic, 76:1, pp. 22-27, Jan. 1979.
10. Shah, Bakula P. (1977, 1980): “Management of Primary & Secondary Sterility till delivery with Aloes Compound & Leptaden in the mofussil and rural areas in India”: 21st All India Obst. & Gynec. Congress, Cuttack, 27-29 Dec. 1977; Antiseptic 77:3, pp. 155-162, March 1980.
11. Shah, Bakula P.; Shah, Pramod H. (1980, 1982): “Non-hormonal Ayurvedic Drugs in the treatment of Primary Infertility”: 1st National Congress on Hormones and Human Reproduction, Bombay, 22-25 Nov. 1980; Current Medical Practice, Vol. 26:12, pp. 363-366, Dec. 1982.
12. Sivaraman, Ramani; Kumari, Sujaya; Kannan, Usha; Dharthi (1976): “Aloes Compound in Sterility”: Antiseptic, 73:7, pp. 366-370, July 1976.
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Important:

This section presents a historical paper published on the Alarsin website. The study described patients treated during 1974–1975 and reports its own methodology, results and statistical analysis. The information should be understood in the historical context of that paper and should not, by itself, be treated as a current clinical recommendation or as contemporary evidence of treatment effectiveness.

The original page states that the material is “for the use only of a registered medical practitioner or a hospital or a laboratory.”