A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF BRIHTYADI LEPA(Chakradatta)AND RAKTAMOKSHANA BY GHATI YANTRA IN CASES OF Hair fall

Phase 2

Completed

Brief Summary: TYPE OF STUDY-

Phase-2, randomized and parallel group study.

PERIOD OF STUDY

Total duration of clinical Trial is of 3 months

FOLLOW UP PERIOD

Follow up of all registered patients will be of one month after the treatment is completed.

SELECTION OF CASES

For the purpose of present clinical trial,cases of Khalitya (Androgenic Alopecia ) will be selected regardless of sex occupation, socioeconomic condition& religion in the age group of 21- 40 years from the OPD / IPD of State Ayurvedic College & Hospital Lucknow.

After clinical examination, History &Lab investigation patients fulfilling the inclusion criteria and exclusion criteria will be enrolled for the clinical trial.

SAMPLE SIZE

Minimum of 60 patients will be selected from OPD/ IPD of State Ayurvedic College & Hospital Lucknow & refered cases from other Hospitals, divided randomly into 3 Groups i.e. Group A, Group B & Group C with approximately 10% drop out.

Group A

In this Group patients will be treated with Brihatyadi Lepa, twice in a week for 3 months (24 sittings).

Group B

In this Group patients will be treated with Raktamokshna by Ghati-Yantra at the interval of 10 days for 3 months ( 9 sittings ).

Group C

In this Group patients will be treated with Brihatyadi Lepa and Raktamokshna by Ghati- Yantra as above for 3 months.

Recruitment & Eligibility

Inclusion Criteria

A-SUBJECTIVE PARAMETERS- 1Patients who give the consent to participate in clinical trial.
2Patients of age group 21-40 years.
Essential Criteriaâ€“Gradual hair fall, more than 100 hairs par day in a couple of weeks.For males, the pattern typically involves loss of the frontal hairline with hair loss at the vertex (or top of the scalp) and progress over time.
For females, the pattern is more variable, but most often spares the frontal hairline and involves diffuse thinning of hair over the crown of the scalp, sparing the back.
This again progress over time.
Non-Essential/Others Criteria a.Darunaka (Dandruff) b.ShirahKandu (Itching on scalp) c.Kesh Tanutva (Thinning of Hairs) d.Kesh Rukshta (Dryness of Hair) e.Kesh Bhoomi Sweda (Sweating on Scalp) B-OBJECTIVE PARAMETERS a.
Total Number of hair loss/day b.After sleep numbers of hairs on Pillow c.During hair wash number of hairs d.During combing hair number of hairs e.Hair pull test f.Hormone test -testosterone Patients having Essential criteria along with minimum 50% of Non-essential parameter will be registered for clinical trial.

Exclusion Criteria

1Cases of any chronic systemic disorders 2Thyroid disorder 3Traumatic hair loss 4Burns, 5 chemotherapy 6Bacterial Infection 7Localized surgery 8Cases with family history of Alopecia.
9More than 75% hair loss.
10Age below 21 year & above 40 year.

Primary Outcome Measures

Name	Time	Method
1To evaluate clinical efficacy of Brihatyadilepa in Khalitya.	3 months
2To evaluate clinical efficacy of Raktamokshna by Ghati-Yantra in Khalitya.	3 months
3Comparative efficacy between Lepan Karma and Raktmokshna.	3 months
4To evaluate cumulative effect of Lepa & Raktamokshna	3 months

Secondary Outcome Measures

Name	Time	Method
1To assess the adverse effect of drug if any.	2To provide scientifically proved,effective management in Khalitya

Locations (1): State Ayurveda College and Hospital
🇮🇳
Lucknow, UTTAR PRADESH, India
State Ayurveda College and Hospital
🇮🇳Lucknow, UTTAR PRADESH, India
Anil Kumar Pandey
Principal investigator
9452861300
anil.edu88@gmail.com